RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque Psoriasis

This research study is for children and teenagers between 4 and 17 years old who have moderate to severe plaque psoriasis, a skin condition causing red, scaly patches. The study is investigating a new medicine called deucravacitinib. Researchers want to find out the right amount of the medicine to give, how well it helps control psoriasis, and if it is safe for young people. The study is split into two groups, younger children and older teenagers, and will check different doses. There's also a long-term part to see how the medicine works over five years. Some participants might receive a placebo, which looks like the study medicine but has no active ingredients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

153

Start

23 Mar 2021

Estimated completion

08 Sep 2033

Plaque Psoriasis

What is this study about?

This study is gathering important information about a new medication called deucravacitinib for young people with moderate to severe plaque psoriasis. Psoriasis is a long-lasting skin condition that causes patches of redness and scales. When it's moderate to severe, it can really impact a young person's daily life. Doctors are looking for new treatments that are effective and safe for this age group.

Researchers want to understand how the body handles deucravacitinib in children and teenagers (this is called 'drug levels'). They also want to see if it helps improve the psoriasis symptoms ('efficacy') and if there are any side effects ('safety'). This helps doctors figure out the best way to use the new medicine.

The study involves different age groups, from 4-year-olds up to 17-year-olds. It starts by carefully checking different medicine amounts to find two suitable doses. Then, these doses will be tested to see how well they work and if they are safe. Some participants might receive a dummy medicine (a placebo) instead of the active medicine to help researchers see the true effects of deucravacitinib. There's also a long-term follow-up for five years to make sure the medicine remains safe and helpful over time.

Key takeaways

This study is testing a new psoriasis medicine (deucravacitinib) for young people.
It's for children and teenagers aged 4 to 17 with moderate to severe plaque psoriasis.
The study aims to find the right dose, check if it works, and assess its safety.
Participants may receive the study medicine or a placebo.
There's an optional long-term follow-up for up to five years.

Who may be eligible?

To join this study, you would typically be a boy or girl with plaque psoriasis, aged between 4 and 17 years old. Your psoriasis should have been present for at least six months and be considered moderate to severe by a doctor. This means your doctor thinks you might need treatments like light therapy or other body-wide medications for your psoriasis.

You wouldn't be able to join if you have other types of psoriasis besides plaque psoriasis, or if you've recently had an infection that needed medical attention. If you've already taken deucravacitinib or a similar medicine in the past, or if you weigh less than certain amounts (like under 30kg for older teens or under 18kg for younger children), you wouldn't be able to take part. Also, if you have or have had certain health conditions, like active tuberculosis, you would not be able to participate. Your doctor will carefully check all these details.

There are other specific rules for joining the study that your doctor will discuss with you to make sure it's the right fit.

Quick self-check

Are you/your child aged between 4 and 17 years old?
Do you/your child have plaque psoriasis that's been present for at least 6 months?
Is the psoriasis considered moderate to severe by a doctor?
Has your doctor suggested your psoriasis might need more than creams alone?
Have you/your child NOT used deucravacitinib or similar medicines before?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll have regular visits to the clinic so doctors can monitor your health and your psoriasis. These visits will involve various assessments, such as physical exams, blood tests, and checking your psoriasis symptoms. You will be given either the study medicine (deucravacitinib) or a placebo, which looks identical but contains no active medicine. You or your child will take this medicine as instructed by the study team.

The initial part of the study involves finding the right dose and checking how well it works and if it's safe. This will last for about a year. If you complete this part, you might have the option to continue into a longer-term part of the study, which could last up to five years. During this long-term phase, the focus will be on observing the safety and overall health of participants over an extended period. All study-related medication and medical care within the study protocol will be provided.

Potential risks and benefits

Taking part in a study like this might have potential benefits; for example, you or your child could receive a new medication that might improve psoriasis, and you'll receive close medical attention. However, there are also potential risks, as with any new medicine. Deucravacitinib might cause side effects, and some are not yet fully known. You might also receive a placebo, meaning your psoriasis might not improve during that time. It's important to remember that participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (63)

Instituto de Neumonologia Y Dermatologia
Ciudad Autonoma de Buenos Aires, Argentina· Recruiting
Psoriahue
Ciudad Autonoma de Buenos Aires, Argentina· Recruiting
CONEXA Investigacion Clinica S.A.
Buenos Aires, Argentina· Recruiting
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, Argentina· Recruiting
Hospital Italiano de Buenos Aires
CABA, Argentina· Recruiting
Consultora Integral de Salud
Córdoba, Argentina· Recruiting
The Skin Hospital
Darlinghurst, Australia· Recruiting
Local Institution - 0002
Westmead, Australia· Withdrawn
Queensland Children's Hospital
Brisbane, Australia· Recruiting
Veracity Clinical Research
Woolloongabba, Australia· Recruiting
Monash Health
Clayton, Australia· Recruiting
Local Institution - 0001
Melbourne, Australia· Completed

+51 more sites — see the official record for the full list.

Common questions

What is plaque psoriasis?

Plaque psoriasis is a common skin condition that causes red, scaly patches on the skin, often on elbows, knees, scalp, and lower back.

What is deucravacitinib?

Deucravacitinib is a new medication being tested to treat psoriasis. This study is trying to understand how it works in young people.

What is a 'placebo' in a study?

A placebo is a 'dummy' medicine that looks like the real medicine but has no active ingredients. It helps researchers compare the effects of the active medicine.

How long will the study last?

The main part of the study is about 1 year, and there's an optional longer part that can last up to 5 years.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your regular medical care.

How to find out more

BMS Study Connect Contact Center www.BMSStudyConnect.com

Clinical.Trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.